Cool-tip ACT2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884524001210), received between Feb 28, 2017 and Mar 30, 2026 — classified as 9 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026No Flow; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE THE DEVICE'S FAILURE TO CIRCULATE.

  Patient problems: Insufficient Information

  MAUDE report 24730090 ↗
• InjuryMar 30, 2026No Flow; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE FAILED TO CIRCULATE, RESULTING IN THE PROCEDURE BEING ABORTED.

  Patient problems: Insufficient Information

  MAUDE report 24729873 ↗
• InjuryMar 30, 2026No Flow; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE DEVICE'S FAILURE TO CIRCULATE.

  Patient problems: Insufficient Information

  MAUDE report 24729826 ↗
• InjuryDec 22, 2025Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE BROKE RESULTING IN THE PROCEDURE BEING ABORTED.

  Patient problems: Insufficient Information

  MAUDE report 23863139 ↗
• InjuryNov 18, 2025No Flow; Appropriate Device Problem Term/Code Not Available; No Flow; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO A CIRCULATION ISSUE, SPECIFICALLY A FAILURE TO CIRCULATE.

  Patient problems: Insufficient Information

  MAUDE report 23584183 ↗
• MalfunctionFeb 22, 2023No Flow; No Flow

  ACCORDING TO THE REPORTED, PRIOR TO RADIO FREQUENCY ABLATION, THE WATER OUTLET PIPE WAS FOUND TO BE OUT OF WATER WHEN THE WATER CYCLE TEST STARTED AFTER THE NEEDED WAS CONNECTED. THE ENTIRE NEEDLE WAS NOT FLOWING THROUGH THE WATER, AND THE MAIN UNIT SHOWED THAT THE TEMPERATURE DID NOT DROP. A NEW NEEDLE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418104 ↗
• MalfunctionMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY FROM JUNE 2014 TO JANUARY 2016 EVALUATED THE EFFICACY OF FEEDING VESSEL ABLATION (FVA) IN THE TREATMENT OF HEPATOCELLULAR CARCINOMA (HCC) LOCATED IN THE LIVER MARGINAL ANGLE (LMA) USING A MEDTRONIC COOL TIP RADIOFREQUENCY ABLATION ELECTRODE. NINE PATIENTS WERE INCLUDED IN THE STUDY WITH THE FOLLOWING REPORTED COMPLICATIONS. TWO PATIENTS HAD FAILED PROCEDURES (DEFINED AS HAVING ANY TUMOR ENHANCEMENT REMAINING AFTER 18 MIN OF FVA OR 3 CYCLES OF ABLATION). THESE TWO PATIENTS WERE REFERRED OUT FOR RESCUE THERAPY INCLUDING REPEATED PERCUTANEOUS ETHANOL INJECTION OR TRANSARTERIAL CHEMOEMBOLIZATION (TACE). OTHER REPORTED COMPLICATIONS INCLUDED ONE CASE OF ASYMPTOMATIC PLEURAL EFFUSION REQUIRING NO MEDICAL INTERVENTION AND ONE CASE OF MODERATE FEVER THAT WAS RELIEVED WITHIN 48 HOURS AFTER AN UNSPECIFIED TREATMENT.

  Patient problems: Fever; Pleural Effusion

  MAUDE report 13666580 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY FROM JUNE (B)(6) TO (B)(6) 2016 EVALUATED THE EFFICACY OF FEEDING VESSEL ABLATION (FVA) IN THE TREATMENT OF HEPATOCELLULAR CARCINOMA (HCC) LOCATED IN THE LIVER MARGINAL ANGLE (LMA) USING A MEDTRONIC COOL TIP RADIOFREQUENCY ABLATION ELECTRODE. NINE PATIENTS WERE INCLUDED IN THE STUDY WITH THE FOLLOWING REPORTED COMPLICATIONS. TWO PATIENTS HAD FAILED PROCEDURES (DEFINED AS HAVING ANY TUMOR ENHANCEMENT REMAINING AFTER 18 MIN OF FVA OR 3 CYCLES OF ABLATION). THESE TWO PATIENTS WERE REFERRED OUT FOR RESCUE THERAPY INCLUDING REPEATED PERCUTANEOUS ETHANOL INJECTION OR TRANSARTERIAL CHEMOEMBOLIZATION (TACE). OTHER REPORTED COMPLICATIONS INCLUDED ONE CASE OF ASYMPTOMATIC PLEURAL EFFUSION REQUIRING NO MEDICAL INTERVENTION AND ONE CASE OF MODERATE FEVER THAT WAS RELIEVED WITHIN 48 HOURS AFTER AN UNSPECIFIED TREATMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13659565 ↗
• MalfunctionNov 23, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE NEEDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND ELECTRODE TO BE COMPLETELY SEVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866385 ↗
• MalfunctionJul 19, 2021Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, RADIOFREQUENCY ABLATION WAS PERFORMED. DURING THE ABLATION TREATMENT, THE ABLATION AREA WAS DEFECTIVE, HAD INCOMPLETE ABLATION AND THE NANO COATING WAS DAMAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194207 ↗
• MalfunctionSep 14, 2020Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, AT THE BEGINNING OF THE CASE THE NEEDLE TEMPERATURE WAS NORMAL, BUT AFTER ENTERING THE BODY, THE NEEDLE TEMPERATURE INCREASED. THE PATIENT REPORTED PAIN. AFTER THE NEEDLE WAS PULLED OUT, THE NEEDLE TIP HAD SOMETHING BLACK ON IT, SIMILAR TO OXIDATION. THE NEEDLE WAS REPLACED, THE TEMPERATURE BECAME NORMAL AND THE PATIENT REPORTED NO DISCOMFORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10532163 ↗
• MalfunctionAug 24, 2020Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, THE CASE WAS PERFORMED WITH NORMAL PROTOCOL, THERE WAS NO BREAK ON THE DEVICE BUT WHEN THE NEEDLE WAS CHECKED, ITS INSULATION PART WAS SCRATCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445823 ↗
• MalfunctionJun 10, 2020Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING RADIOFREQUENCY ABLATION, THE ABLATION RANGE WAS DEFECTIVE AND THE NANO COATING WAS DAMAGED. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10137705 ↗
• MalfunctionJan 2, 2020Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING A ABLATION FOR LIVER CANCER, THE DEVICE WAS PUNCTURED USING THE INDWELLING NEEDLE. EVEN THOUGH THE ACTIVATION WAS STARTED, THE RESISTANCE VALUE DIDN'T INCREASE AFTER A BREAK. BECAUSE THE BUBBLE SPREAD WAS DIFFERENT FROM USUAL, THE NEEDLE WAS REMOVED FOR ONCE. WHEN CHECKING, THE INSULATION COATING WAS NOTED TO BE CURLED. A NEW NEEDLE WAS USED AND THE OPERATION WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538885 ↗
• MalfunctionOct 28, 2019Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CORD OF THE PAD WAS DISENGAGED. REPLACED WITH NEW SIMILAR DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9243913 ↗
• MalfunctionOct 9, 2019Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE COATING PART WAS FOUND DAMAGED, BUT NOTHING DISENGAGED FROM THE DEVICE. REOPERATION WAS NOT REQUIRED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9170264 ↗
• MalfunctionMar 13, 2019Device Alarm System; Temperature Problem; Device Alarm System; Temperature Problem

  ACCORDING TO THE REPORTER, DURING ABLATION, THE DEVICE HAD AN ALARM OF HIGH IMPEDANCE. REPLACED WITH ANOTHER SIMILAR DEVICE AND IT WORKED FINE WHICH COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8418305 ↗
• MalfunctionMar 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED JANUARY 2007 TO DECEMBER 2016, THIS STUDY AIMED AT EVALUATING THE HISTOLOGIC RESPONSE AFTER RFA OF SMALL HCCS ARISING IN CIRRHOSIS. DATA WERE REVIEWED FROM 78 PATIENTS WITH DE NOVO EARLY-STAGE HEPATOCELLULAR CARCINOMA (HCCS) WHO WERE TREATED WITH RFA AND SUBSEQUENTLY TRANSPLANTED. PERCUTANEOUS RFA WAS PERFORMED USING A COOL-TIP SINGLE NEEDLE (COOL-TIP RADIOFREQUENCY ELECTRODE; RADIONICS, MINNEAPOLIS, USA) HAVING A LENGTH OF 20 CM WITH AN EXPOSED TIP OF 2 OR 3 CM. THE LENGTH OF THE EXPOSED TIP USED DEPENDED ON THE TUMOR DIMENSIONS. THE TOTAL NUMBER OF RFA SESSIONS WAS 92. DURING THESE SESSIONS, 14 PATIENTS HAD SOME COMPLICATIONS FOR A TOTAL OF 18 (19.6%) EVENTS, BUT ONLY 1 INFECTIOUS COMPLICATION GRADED AS 3 (DEFINABLE AS MAJOR) OCCURRED, RETURNING A MAJOR COMPLICATION RATE OF ONLY 1.1%. DETAILS ARE REPORTED IN TABLE 4; GRADE 1-2 PLEURAL EFFUSION= 3. NOTABLY, MOST OF THE COMPLICATIONS WERE GRADED AS MINOR, AND MORBIDITY IN ABLATED PATIENTS HAVING THE LARGEST TUMOR >3 CM WAS SIGNIFICANTLY HIGHER (35.0%) THAN THAT OF PATIENTS HAVING THE LARGEST TREATED TUMOR =3 CM (9.7%; P = 0.01). NO NEEDLE TRACT SEEDING AMONG 125 TREATED NODULES

  Patient problems: Pleural Effusion

  MAUDE report 8410363 ↗
• MalfunctionMar 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED JANUARY 2007 TO DECEMBER 2016, THIS STUDY AIMED AT EVALUATING THE HISTOLOGIC RESPONSE AFTER RFA OF SMALL HCCS ARISING IN CIRRHOSIS. DATA WERE REVIEWED FROM 78 PATIENTS WITH DE NOVO EARLY-STAGE HEPATOCELLULAR CARCINOMA (HCCS) WHO WERE TREATED WITH RFA AND SUBSEQUENTLY TRANSPLANTED. PERCUTANEOUS RFA WAS PERFORMED USING A COOL-TIP SINGLE NEEDLE (COOL-TIP RADIOFREQUENCY ELECTRODE; RADIONICS, MINNEAPOLIS, USA) HAVING A LENGTH OF 20 CM WITH AN EXPOSED TIP OF 2 OR 3 CM. THE LENGTH OF THE EXPOSED TIP USED DEPENDED ON THE TUMOR DIMENSIONS. THE TOTAL NUMBER OF RFA SESSIONS WAS 92. DURING THESE SESSIONS, 14 PATIENTS HAD SOME COMPLICATIONS FOR A TOTAL OF 18 (19.6%) EVENTS, BUT ONLY 1 INFECTIOUS COMPLICATION GRADED AS 3 (DEFINABLE AS MAJOR) OCCURRED, RETURNING A MAJOR COMPLICATION RATE OF ONLY 1.1%. DETAILS ARE REPORTED IN TABLE 4; GRADE 1-2 CARDIAC ARRHYTHMIA=1, GRADE 1-2 BLEEDING=3. NOTABLY, MOST OF THE COMPLICATIONS WERE GRADED AS MINOR, AND MORBIDITY IN ABLATED PATIENTS HAVING THE LARGEST TUMOR >3 CM WAS SIGNIFICANTLY HIGHER (35.0%) THAN THAT OF PATIENTS HAVING THE LARGEST TREATED TUMOR =3 CM (9.7%; P = 0.01). NO NEEDLE TRACT SEEDING AMO

  Patient problems: Arrhythmia; Blood Loss

  MAUDE report 8410332 ↗
• MalfunctionNov 21, 2018Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, DURING ABLATION, THE DEVICE DETECTS THE NEEDLE AND SHOWS THAT THE IMPEDANCE IS TOO HIGH. IT WAS REPLACED BY THE NEW DEVICE BUT STILL DETECTS THE NEEDLE HAD AN IMPEDANCE THAT IS TOO HIGH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8096465 ↗
• MalfunctionSep 13, 2018No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING A PROCEDURE FOR A LIVER TUMOR, THE DEVICE HAD A LOOP AND LEAK PROBLEM ON ITS WATER PIPE. THE DOCTOR HAD TO USE MORE NEEDLE SETS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7873259 ↗
• InjuryJul 24, 2018Fracture; Component Missing; Component Missing

  ACCORDING TO THE REPORTER, AFTER PUNCTURING THE RADIOFREQUENCY ELECTRODE PACKAGE IN AN ABLATION PROCEDURE, THE CONNECTION TUBE WAS OPENED AND THE FRACTURE WAS FOUND. THEY WERE UNABLE TO PERFORM THE OPERATION DUE TO THIS EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713658 ↗
• MalfunctionJul 3, 2018Ambient Temperature Problem; Ambient Temperature Problem

  ACCORDING TO THE REPORTER, DURING A RADIOFREQUENCY ABLATION (RFA) FOR LIVER CANCER. THE PATIENT HAD MULTIPLE TUMORS SO ABLATION WAS PERFORMED MANY TIMES. IN TWO SESSIONS AMONG THOSE, IMPEDANCE DID NOT CHANGE AT ALL FOR 10 MIN. OF ABLATION AND BREAK DID NOT OCCUR. IT WAS CONFIRMED TO BE ABLATED THROUGH ECHO SO THE PROCEDURE WAS FINISHED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7660388 ↗
• InjuryMar 22, 2018Aborted Charge; No Flow; Aborted Charge; No Flow

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE FAILED TO CIRCULATE. THE PROCEDURE WAS INTERRUPTED. THERE WAS NO INJURY CAUSED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363329 ↗
• MalfunctionJan 10, 2018Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PRODUCT WAS CONNECTED TO THE GENERATOR, TEMPERATURE WAS NOT STABLE. NO PATIENT INVOLVEMENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE.

  Patient problems: No Patient Involvement

  MAUDE report 7180603 ↗